HealthyBRAIN3NCT06222385
Applied Cognition Benchmarking Study
A study testing Device measurements during overnight sleep and morning wake and Device measurements during overnight wake and morning sleep in people with Healthy, run by Applied Cognition at 1 site in United States.
Trial summary
This is a cross-over randomized study to validate the Sponsor investigational medical device against measurements of glymphatic function from MRI-based neuroimaging, EEG, blood biomarkers and cognitive tests in healthy older volunteers. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Device measurements during overnight sleep and morning wake and Device measurements during overnight wake and morning sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must have a Montreal Cognitive Assessment (MoCA) score at least 26.
- Participants must have a Geriatric Depression Scale (GDS) 15-item score of 4 or less.
Who cannot join
- Participants with a formal diagnosis of any sleep disorder (e.g., sleep apnea on positive-airway-pressure (PAP) therapy, insomnia, restless leg syndrome, circadian rhythm sleep disorder, parasomnia).
- Participants with a history of significant neurological disease or history of epilepsy.
- Participants with cardiovascular disease or cardiovascular risk factors (smoking or hypertension).
- Participants with diabetes.
- Participants with traumatic brain injury, or serious mental illness including bipolar disorder, schizophrenia, major depressive disorder or post-traumatic stress disorder.
- Participants who have taken in the past 30 days prescribed or overthe- counter (OTC) stimulants, sleeping medications, or psychiatric medications including antidepressants.
Show all 19Show fewer
- Participants who consume more than 400 mg/day of caffeine. Participants will be required to not consume caffeine beginning 12pm on the day-of the sleep study.
- Female Participants who consume more than 3 alcoholic drinks on any day or more than 7 drinks per week. Male participants who consume more than 4 alcoholic drinks on any day or more than 14 drinks per week.
- Participants planning travel to alternate time zones within two weeks of study participation
- Participants with travel plans or conflicts that would prevent them from either Study Visit.
- Participants who are enrolled in other research studies and are receiving an investigational drug within 30 days of the planned start date.
- Participants who have any condition that, in the opinion of the Sponsor Principal Investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements.
- Participants with absolute or relative contraindications to MRI imaging based on current up-to-date screening questionnaires including claustrophobia, inability to lie still on their back for 30-45 minutes or require sedation prior to the MRI.
- Participants with a head circumference greater than 60 cm that would prevent use of a high-resolution 64 channel MRI head coil required for this study
- Participants who have a pre-planned surgery or medical procedure that would interfere with the conduct of the study.
- Participants who have an implanted medical device or contraindications that would exclude MRIs
- Participants with a serious infection requiring medical attention in the past 30 days
- Participants with a diagnosis of substance use-disorder in the past 2 years.
- Participants with known acute or chronic kidney disease and/or compromised GFR.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health - Precision Health Research Center
The Villages, Florida, 32159
About this study
Official title: Measuring and Monitoring Brain Health in Older Adults: The Applied Cognition Glymphatic Function Study at The Villages
This is a cross-over randomized study to validate the Sponsor investigational medical device against measurements of glymphatic function from MRI-based neuroimaging, EEG, blood biomarkers and cognitive tests in healthy older volunteers.
Read the detailed description
The study population will consist of healthy individuals, ages 55 to 65, that are cognitively normal and do not have a medical history of neurological or sleep disorder, cardiovascular disease, hypertension, or diabetes. The objectives of this study are to define whether sleep- and wake-associated device measurements (i) faithfully reflect glymphatic function measured by gold-standard contrast enhanced MRI and non-invasive MRI-based measures of glymphatic function; (ii) replicate pre-clinical findings between sleep EEG power bands and glymphatic flow; (iii) predict plasma levels of Alzheimer's disease (AD)-related biomarkers; and (iv) predict morning cognitive performance.
- Conditions
- Healthy
- Being tested
- Device measurements during overnight sleep and morning wake, Device measurements during overnight wake and morning sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device measurements during overnight sleep and morning wakeDiagnostic test
Overnight period and morning period device measurements
Device measurements during overnight wake and morning sleepDiagnostic test
Overnight period and morning period device measurements
| Study group | Role | What they receive |
|---|---|---|
| Sleep Opportunity-Sleep Deprivation | Experimental | Participant randomized to overnight sleep period with a morning wake period on first visit of cross-over study. Receives: Diagnostic Test: Device measurements during overnight sleep and morning wake |
| Sleep Deprivation-Sleep Opportunity | Experimental | Participant randomized to overnight sleep deprivation period with a morning recovery sleep period on first visit of cross-over study. Receives: Diagnostic Test: Device measurements during overnight wake and morning sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-enhanced MRI
Overnight sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by ROI parenchymal signal intensity using gold-standard contrast-enhanced MRI for gray and white matter ROI.
Measured: Immediately after the overnight sleep/wake period
Non-invasive MRI - diffusion-based intravoxel incoherent motion
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using diffusion-based intravoxel incoherent motion (IVIM)-MRI (long-distance water transport) (diffusion signal, a.u.).
Measured: Immediately before and immediately after each sleep/wake period
Non-invasive MRI - fast functional MRI
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using fast functional MRI (f-MRI) low-frequency vasomotor oscillations, Hz.
Measured: Immediately before and immediately after each sleep/wake period
Non-invasive MRI - T1/FLAIR-based assessment
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using T1/FLAIR-based assessment of MRI-visible perivascular spaces (MVPVS) that are structural indicators of perivascular impairment, (a.u.).
Measured: Immediately before and immediately after each sleep/wake period
Non-invasive MRI - multi-echo arterial spin-labeling
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using multi-echo arterial spin-labeling (ME-ASL)-MRI (glial-vascular water transport) (flow in ml/sec).
Measured: Immediately before and immediately after each sleep/wake period
Non-invasive MRI - phase-contrast
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using phase-contrast (PC)-MRI (aqueductal cerebral spinal fluid (CSF) flow) (flow in ml/sec).
Measured: Immediately before and immediately after each sleep/wake period
Secondary outcomes (6)
Sleep EEG
Device overnight sleep measurements (impedances in milli-ohms) correlations with overnight recorded sleep EEG power bands (relative delta, theta, alpha and beta power in %) and heart rate replicate pre-clinical correlations of glymphatic flow (measured using 2-photon microscopy in a.u.) with EEG power bands (relative delta, theta, alpha and beta power in %) and heart rate.
Measured: Measurements sampled every 5 to 10 minutes during the overnight sleep period
Blood biomarkers
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic clearance measured by amyloid beta40, beta42, n-tau 181, n-tau 217, p-tau 181, p-tau 217 blood biomarkers
Measured: Immediately before and immediately after each sleep/wake period
Cognitive function - trail making tests A&B
Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on Trail Making Tests A\&B (time in seconds).
Measured: Immediately after the sleep/wake period
Cognitive function - symbol digit modality test
Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on symbol digit modality test (SDMT) (number correct).
Measured: Immediately after the sleep/wake period
Cognitive function - psychomotor vigilance test
Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on psychomotor vigilance test (PVT) (mean and standard deviation of reaction time).
Measured: Immediately after the sleep/wake period
Cognitive function - digits forward recall
Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on digits forward recall (maximum number of correctly recalled digits).
Measured: Immediately after the sleep/wake period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start7 Nov 2022
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Cognition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida Health
- Responsible party
- Sponsor
- Investigators
- Carla Vandeweerd, PhD, Principal investigator, UF Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222385
- Sponsor's protocol ID
- AC.2022.02
- Acronym
- BRAIN3
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Monitoring Brain Health in Older Adults: The Applied Cognition Glymphatic Function Study at The Villages
- ClinicalTrials.gov ID
- NCT06222385
- Acronym / sponsor ID
- BRAIN3 / AC.2022.02
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Applied CognitionIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida Health
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-over randomized study to validate the Sponsor investigational medical device against measurements of glymphatic function from MRI-based neuroimaging, EEG, blood biomarkers and cognitive tests in healthy older volunteers.
Detailed description
The study population will consist of healthy individuals, ages 55 to 65, that are cognitively normal and do not have a medical history of neurological or sleep disorder, cardiovascular disease, hypertension, or diabetes. The objectives of this study are to define whether sleep- and wake-associated device measurements (i) faithfully reflect glymphatic function measured by gold-standard contrast enhanced MRI and non-invasive MRI-based measures of glymphatic function; (ii) replicate pre-clinical findings between sleep EEG power bands and glymphatic flow; (iii) predict plasma levels of Alzheimer's disease (AD)-related biomarkers; and (iv) predict morning cognitive performance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cross-over randomized study
| Arm | Type | Receives |
|---|---|---|
| Sleep Opportunity-Sleep Deprivation | Experimental | Diagnostic Test: Device measurements during overnight sleep and morning wakeParticipant randomized to overnight sleep period with a morning wake period on first visit of cross-over study. |
| Sleep Deprivation-Sleep Opportunity | Experimental | Diagnostic Test: Device measurements during overnight wake and morning sleepParticipant randomized to overnight sleep deprivation period with a morning recovery sleep period on first visit of cross-over study. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must have a Montreal Cognitive Assessment (MoCA) score at least 26.
- Participants must have a Geriatric Depression Scale (GDS) 15-item score of 4 or less.
Key exclusion criteria (19 listed)
- Participants with a formal diagnosis of any sleep disorder (e.g., sleep apnea on positive-airway-pressure (PAP) therapy, insomnia, restless leg syndrome, circadian rhythm sleep disorder, parasomnia).
- Participants with a history of significant neurological disease or history of epilepsy.
- Participants with cardiovascular disease or cardiovascular risk factors (smoking or hypertension).
- Participants with diabetes.
- Participants with traumatic brain injury, or serious mental illness including bipolar disorder, schizophrenia, major depressive disorder or post-traumatic stress disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device measurements during overnight sleep and morning wakeOvernight period and morning period device measurements | Diagnostic test | Sleep Opportunity-Sleep Deprivation |
| Device measurements during overnight wake and morning sleepOvernight period and morning period device measurements | Diagnostic test | Sleep Deprivation-Sleep Opportunity |
Primary outcome
Contrast-enhanced MRI
Time frame: Immediately after the overnight sleep/wake period
Overnight sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by ROI parenchymal signal intensity using gold-standard contrast-enhanced MRI for gray and white matter ROI.
Non-invasive MRI - diffusion-based intravoxel incoherent motion
Time frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using diffusion-based intravoxel incoherent motion (IVIM)-MRI (long-distance water transport) (diffusion signal, a.u.).
Non-invasive MRI - fast functional MRI
Time frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using fast functional MRI (f-MRI) low-frequency vasomotor oscillations, Hz.
Non-invasive MRI - T1/FLAIR-based assessment
Time frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using T1/FLAIR-based assessment of MRI-visible perivascular spaces (MVPVS) that are structural indicators of perivascular impairment, (a.u.).
Non-invasive MRI - multi-echo arterial spin-labeling
Time frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using multi-echo arterial spin-labeling (ME-ASL)-MRI (glial-vascular water transport) (flow in ml/sec).
Non-invasive MRI - phase-contrast
Time frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using phase-contrast (PC)-MRI (aqueductal cerebral spinal fluid (CSF) flow) (flow in ml/sec).
6 secondary outcomes
Sleep EEG
Time frame: Measurements sampled every 5 to 10 minutes during the overnight sleep period
Blood biomarkers
Time frame: Immediately before and immediately after each sleep/wake period
Cognitive function - trail making tests A&B
Time frame: Immediately after the sleep/wake period
Cognitive function - symbol digit modality test
Time frame: Immediately after the sleep/wake period
Cognitive function - psychomotor vigilance test
Time frame: Immediately after the sleep/wake period
Cognitive function - digits forward recall
Time frame: Immediately after the sleep/wake period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Vandeweerd, PhD principal investigator
UF Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device measurements during overnight sleep and morning wake and Device measurements during overnight wake and morning sleep in people with Healthy, run by Applied Cognition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-enhanced MRI (time frame: Immediately after the overnight sleep/wake period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.